Lotte Biologics Signs Contract Manufacturing Agreement with Rakuten Medical for Head and Neck Cancer Treatment

[San Francisco (USA) = Reporter Jung Sang-hee] Lotte Biologics will provide contract manufacturing (CMO) services for Rakuten Medical’s head and neck cancer treatment.
Lotte Biologics announced on the 13th (local time) that it had signed a contract with Rakuten Medical in San Francisco, USA, where the J.P. Morgan Healthcare Conference is being held. The contracted product is a head and neck cancer treatment based on photoimmunotherapy. Photoimmunotherapy is a treatment that enhances efficacy and safety by binding a light-reactive substance to a targeted antibody and then irradiating the tumor site with red light to selectively destroy the target cells.
The Rakuten Medical therapy in question has already secured commercial use experience in Japan under a conditional early approval framework from the regulatory authorities. Global Phase 3 clinical trials are currently underway in multiple countries, including the USA and Taiwan, and clinical trials are also scheduled to begin in Ukraine and Poland.
Lotte Biologics plans to support production through its Syracuse Bio Campus in New York State. The Syracuse Bio Campus recently began operating its antibody-drug conjugate (ADC) manufacturing facility. With the first plant at the Songdo Bio Campus also scheduled for completion this August, Lotte Biologics aims to accelerate the establishment of a dual-site global production infrastructure and further strengthen its position as a global Contract Development and Manufacturing Organization (CDMO) specializing in ADCs.
A Lotte Biologics official said, “Through this contract, the two companies plan to gradually build a supply chain that extends from the clinical stage to commercialization,” adding, “As our mid- to long-term partnership for the manufacturing of monoclonal antibody (mAb) and ADC products has now materialized into an actual contract, we will use this as a springboard to enhance brand recognition in global markets such as the USA and Japan and to pursue active contract-winning activities.”
wonder@fnnews.com Jung Sang-hee Reporter